Condition category
Nutritional, Metabolic, Endocrine
Date applied
18/08/2017
Date assigned
25/08/2017
Last edited
24/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hypoxic training involves training while breathing hypoxic (low oxygen) air. Although not commonly used, hypoxic training may be beneficial for people with clinical conditions such as coronary artery (heart) disease and chronic obstructive pulmonary (lung) disease. However, the effects of hypoxic training vary greatly according to the oxygen level, exercise intensity, time and duration, and also vary considerably among individuals. The aim of this study is to examine the effects of hypoxic training on factors related to metabolic syndrome (a combination of diabetes, high blood pressure and obesity).

Who can participate?
Men aged 18 or over

What does the study involve?
Participants are divided into two groups based on their body mass index. Participants in the overweight and normal-weight groups are then randomly allocated into either the hypoxic exercise group (hypoxic overweight and hypoxic normal-weight) or the normoxic exercise group (normoxic overweight and normoxic normal-weight). Participants perform treadmill exercise three days per week for four weeks under either hypoxic (low oxygen) or normoxic (normal oxygen) conditions, for 50 minutes (including 5 minutes warm-up and cool-down periods) after a 30-minute rest period. Markers of metabolic syndrome are measured using blood sampling at the start and the end of the study.

What are the possible benefits and risks of participating?
These results may show that hypoxic training could be useful for improving arterial (blood vessel) stiffness, circulatory system function, body composition and metabolism in adult men.

Where is the study run from?
Gifu University (Japan)

When is the study starting and how long is it expected to run for?
March 2014 to May 2015

Who is funding the study?
University of Ulsan (South Korea)

Who is the main contact?
Dr Sohee Shin

Trial website

Contact information

Type

Public

Primary contact

Dr Sohee Shin

ORCID ID

Contact details

School of Exercise and Sport Science
University of Ulsan
93 Daehak-ro
Nam-gu
Ulsan
44610
Korea
South

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

-

Study information

Scientific title

Influences of short-term normobaric hypoxic training on metabolic syndrome-related markers in overweight and normal-weight men: a randomised controlled trial

Acronym

Study hypothesis

Short-term normobaric hypoxic training influences metabolic syndrome-related markers in overweight and normal-weight men positively.

Ethics approval

Institutional review board of the Gifu University School of Medicine, 06/03/2013, ref: 24-392

Study design

Interventional randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Metabolic syndrome

Intervention

Forty-one Japanese men were included and were divided into two groups based on their body mass indexes (BMIs): BMI ≥25 or BMI <25. Participants in the overweight and normal-weight groups were randomised into the hypoxic exercise group (hypoxic overweight, HO; hypoxic normal-weight, HN) or the normoxic exercise group (normoxic overweight, NO; normoxic normal-weight, NN). Subjects performed treadmill exercise three days per week for four weeks at an exercise intensity of 60% maximum heart rate (HR), under either normobaric hypoxic or normobaric normoxic conditions, for 50 min (including 5 min warm-up and cool-down periods) after a 30-min rest period. Duration of follow-up: 4 weeks.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Metabolic syndrome-related markers, measured using blood sampling at baseline and 1 month

Secondary outcome measures

Body composition, measured using body composition analyzer (TANITA Co., Tokyo, Japan) at baseline and 1 month

Overall trial start date

30/03/2014

Overall trial end date

30/05/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. All patients admitted to one of the participating wards
2. Aged 18 years or over
3. Able to provide informed consent to participate

Participant type

Patient

Age group

Adult

Gender

Male

Target number of participants

Planned sample size: 40: Japanese sample size: 40

Participant exclusion criteria

1. Coronary heart disease
2. Cardiac insufficiency
3. Pulmonary disease
4. Uncontrolled hypertension

Recruitment start date

30/03/2014

Recruitment end date

30/08/2014

Locations

Countries of recruitment

Japan

Trial participating centre

Gifu University
501-1194

Sponsor information

Organisation

University of Ulsan

Sponsor details

93 Daehak-ro
Nam-gu
Ulsan
44610
Korea
South

Sponsor type

University/education

Website

http://www.ulsan.ac.kr/

Funders

Funder type

University/education

Funder name

University of Ulsan

Alternative name(s)

UOU

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Korea, South

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Sohee Shin.

Intention to publish date

01/11/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes